Clinical Research in Lebanon: The

Clinical Research
Clinical Research in Lebanon:
The Pharmaceutical Industry Perspective
lot to be done: The increase in the incidence of diseases
associated with aging – such as cancer, type 2 diabetes,
Alzheimer’s disease and osteoporosis to mention a fewdemonstrate that the pace of medical progress should be
sustained. Today, nearly 3,000 potential drugs are in the
development phases in the pharmaceutical industry. We
have much more scientific knowledge and data than ever
before, and we have the means to translate this science into
new therapies.
Dr. Linda Daou
General Manager for Lilly
Near East & Chairperson
of the Lebanese Group of
International Research Based
Pharmaceutical Companies
Alain Zogheib
PHARM D, MPH
Senior Clinical Research
Manager,
Abbvie pharmaceuticals,
Gulf & Levant area
Earlier this year, there were 206 clinical research studies
in Lebanon which were registered at the United States
government clinical trials database (www.clinicaltrials.
gov). The steady increase in the number of clinical trials
in Lebanon during the last decade has been accompanied
by a surge in the demand for resources and expertise in the
clinical research field. This is good news for patients who
are enrolled in clinical studies on new compounds under
investigation, and who can access innovative medications
that improve their health.
The mission of the biopharmaceutical industry is to
discover, develop, manufacture and market innovative
medicines that make a difference for patients. Research and
Development (R&D) is at the origin of the benefits brought
to patients, and more generally to disease prevention and
healthcare. Indeed, the pharmaceutical industry has a major
role in the longevity of people around the world, as well
as in their quality of life. Millions of “death sentences”
were lifted with the fatal illnesses that became curable or
treated as chronic diseases. Nevertheless and despite the
amazing progress over the past 50 years, there remains a
14 | HUMAN & HEALTH | N°28 - Summer 2014
The escalation in the costs of new drug development is
an important challenge faced by the industry. Patent
expirations between 2010 and 2014 have resulted in
an estimated loss of $113 billion yearly. Companies are
looking for creative approaches in order to accomplish
their mission in drug development.
The pharmaceutical industry strives to reduce the lead time
until the medications are brought to the patients. In this
regard, the globalization of clinical trials, which has taken
place over the last two decades along with the expansion
into new geographical areas, has helped significantly.
Emerging markets offer a great potential for clinical trials,
due to the relatively quick initial phase and the substantial
number of patients.
Why is Lebanon a place of choice for clinical trials?
The answer lies in the well-defined and bureaucracyfree approval processes, the developed healthcare
infrastructure, the expertise of healthcare providers,
the relative affordability of healthcare services and the
relatively high prevalence of certain chronic diseases.
Therefore, Lebanon presents definite advantages compared
to the United States, Western Europe and other countries
in the region.
The clinical trials in oncology and hematology are the
most frequent in Lebanon, followed by infectious diseases,
neurology, cardiology and rheumatology. However, in spite
of a favorable environment, the global pharmaceutical
companies face several challenges in the implementation
of clinical trials in accordance with good clinical practices
standards and global research guidelines. The choice of
the site is critical in order to ensure that all the privacy
and ethical requirements for medical research are met.
The site (healthcare center) should have a dedicated and
trained team for the conduct of clinical trials, including the
necessary documentation. Moreover, an effective Ethics
Committee, with clear policies and procedures, should be
in place for proper oversight and for the welfare of study
participants.
In order to enhance further the development of clinical
research in Lebanon, we need a collaborative effort from all
the stakeholders involved. Everyone will ultimately benefit
from such an undertaking. In the absence of registries for
some diseases, the product related information issued from
clinical trials, as well as the data from epidemiological
studies which is frequently supported by the pharmaceutical
companies, can guide healthcare policy decisions.
The reinforcement of Lebanon’s position as a regional hub
for clinical research is a shared responsibility.
In order to succeed, we need a coordinated approach
that streamlines the efforts of regulators, pharmaceutical
companies, clinical research organizations, academicians
and professional and advocacy groups. It is essential to
avail a stable, transparent, and predictable regulatory
framework as well as solid review and control processes;
in addition to qualified personnel that operates with the
highest clinical practices standards.
By nurturing medical innovation, we will continue the
superb progress that transformed human life in the 20th
century and add immense value to health, productivity,
and life in itself.
Infos
Aluminium: Dangereux pour la Santé ?
L’aluminium a longtemps été considéré comme étant inoffensif pour l’homme en raison de sa très faible absorption
intestinale par voie orale. Cependant, en 2000, la cohorte
PAQUID révélait un risque de développer une démence
ou la maladie d’Alzheimer en cas d’exposition à une eau
contenant une certaine concentration d’aluminium. Ce
risque serait 2,2 à 2,3 fois supérieur pour les personnes
résidant dans des régions où la concentration en aluminium est supérieure à 0,1 mg/L. Or, l’Organisation Mondiale de la Santé (OMS) a fixé la concentration maximale autorisée à 0,2 mg/L d’eau. Cette concentration est
liée à la présence de sulfate d’aluminium, utilisé dans
le processus d’assainissement de l’eau afin de la rendre
potable. Mais ce n’est pas le seul problème: l’eau n’est
pas le seul vecteur d’exposition à l’aluminium. On sait
aujourd’hui que l’alimentation en contient, notamment à
cause des additifs alimentaires ou des emballages. Les
risques d’être exposé à l’aluminium sont donc très importants.
HUMAN & HEALTH | N°28 - Summer 2014 | 15